The ICALIC Accuracy Validation in Geneva Study | NCT02790697

Studies
The ICALIC Accuracy Validation in Geneva Study

NCT02790697

Sponsor

University Hospital, Geneva

Status

Unknown status

Last Update Posted

Sep 27, 2019Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Critical Illness

Interventions

Indirect calorimetry

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 10, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2019Estimated

First Submitted Date

May 31, 2016

First Submission Date that Met QC Criteria

May 31, 2016

First Posted Date

Jun 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2019

Last Update Posted Date

Sep 27, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Claude Pichard, Claude Pichard, MD, PhD, University Hospital, GenevaPrincipal Investigator

Lead Sponsor

University Hospital, GenevaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims at validating the accuracy of the new indirect calorimeter (Q-NRG, COSMED, Italy), developed for the ICALIC multicenter study. The validation of accuracy will only be conducted in Geneva center.

The measurements made with the new calorimeter will be compared to the measurements by the mixing chamber method using a mass spectrometer (MAX300-LG, Extrel, USA) for gas composition analysis.

Detailed Description

Indirect calorimetry is a method to measure energy expenditure of human subjects by analyzing patient breath gas to measure the amount (volume) of oxygen consumption (VO2) and CO2 production (VCO2). Energy expenditure is calculated by the Weir's equation using the measured VO2 and VCO2 values.

The new calorimeter is equipped with a disposable in-line pneumotach flowmeter, which measures the flow of exhaled gas of patients directly within the mechanical ventilator circuit. It also samples small amount of inhaled and exhaled gas to measure the inhaled and exhaled O2 and CO2 compositions. The new dynamic micro-mixing chamber technique is used to meaure VO2 and VCO2 to derive the energy expenditure.

The mass spectrometer measures the inhaled and exhaled gas compositions. The mass spectrometer samples inhaled gas from the mechanical ventilator circuit. A mixing chamber system is used to collect the expired gas from the outlet of the mechanical ventilator. The collected gas is measured for the second time after diluting with a constant flow of ambient air, which is monitored by an independent mass flow meter. The volume of the expired gas is calculated by comparison of the concentrations of exhaled gas before and after the dilution. The measurements will be used to calculate the VO2 and VCO2 to derive the energy expenditure.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mechanically ventilated ICU patient		Indirect calorimetry measurements will be conducted using the new calorimeter and the mass spectrometer system at the same time for all enrolled patients.	Other: Indirect calorimetry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Indirect calorimetry	Other	Indirect calorimetry will be conducted using the new calorimeter and mixing chamber method using the mass spectrometer.	Mechanically ventilated ICU patient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of Energy expenditure	Energy expenditure calculated as a result of VO2 and VCO2 measurements	immediately after the measurement

Secondary Outcomes

Measure	Description	Time Frame
Accuracy of VO2	Volume of oxygen consumption	immediately after the measurement
Accuracy of VCO2	Volume of CO2 production	immediately after the measurement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Mechanically ventilated adult ICU patients

Exclusion Criteria:

Fraction of inhaled oxygen (FIO2) > 70%
Positive end expiratory pressure (PEEP) >10cmH2O
Peak ventilatory pressure > 30cmH2O
Presence of air leaks from thoracic drain tube
Changes in vasoactive agent dose (>20%, <1 hr before and/or during IC)
Agitation or change in sedative dose (>20%, <1 hr before and/or during IC)
Change in body temperature (>0.5°C, <1 hr before and/or during IC)
Expected duration of ICU stay < 24 hours
Expected survival of the patient < 24 hours

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Mechanically ventilated adult ICU patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Taku Oshima, MD,PhD	Contact	+41 79 5534780		Oshima.Taku@hcuge.ch
Severine Graf	Contact			Severine.Graf@hcuge.ch

Overall Officials

Name	Affiliation	Role
Claude Pichard, MD, PhD	Clinical Nutrition, Geneva University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service of Intensive Care, Geneva University Hospital	Recruiting	Geneva		1211	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002153	Calorimetry, Indirect

Ancestor Terms

ID	Term
D002151	Calorimetry
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided